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1.
Artigo em Inglês | MEDLINE | ID: mdl-33027390

RESUMO

The aim of the study was to assess the factors associated with mother-to-child transmission (MTCT) of HIV. The study design is a retrospective cohort. The population consisted of 323 HIV-positive mothers and their newborns, attended at the Perinatal Nucleus/HUPE-UERJ, municipality of Rio de Janeiro, in the period of 2007-2018. The average age of mothers was 27 years (14-44), with 12.7% (41) of adolescents. The majority (66.8%) knew they were infected during pregnancy: 39.4% in the current pregnancy and 27.4% in a previous pregnancy. The incidence of MTCT was 2.7% in 2007-2009, 1% in 2010-2015 and 0 in 2016-2018. The viral load in the 3rd trimester of pregnancy was > 1.000 copies/mL or unknown in all mothers with positive newborns and in 19% (42/221) of mothers with negative newborns (p=0.003). The duration of antiretroviral use was > 4 weeks in 92.3% (264/286) of mothers with HIV-negative newborns and in 2 in the HIV-positive group (p=0.004). One of the 4 infected newborns and 2 of the negative ones did not use oral zidovudine (p=0.04). There was no association between amniorrhexis and MTCT (p=0.99), with the Apgar score in the 5th minute of life (p=0.96), with marital status (p=0.54), ethnicity (p=0.65), adolescence (p=0.42), mode of delivery (p=0.99), beginning of prenatal care (p=0.44) or with maternal comorbidities (p=0.48). The conclusion of the study points out that the main factors associated with MTCT are the elevated maternal viral load in the 3rd trimester, the time of use of ART and the non-administration of zidovudine for the newborns.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Transmissão Vertical de Doença Infecciosa/estatística & dados numéricos , Complicações Infecciosas na Gravidez/tratamento farmacológico , Adolescente , Adulto , Fármacos Anti-HIV/administração & dosagem , Feminino , Infecções por HIV/epidemiologia , Humanos , Recém-Nascido , Masculino , Gravidez , Complicações Infecciosas na Gravidez/epidemiologia , Estudos Retrospectivos , Adulto Jovem
2.
Lancet HIV ; 7(10): e666-e676, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33010240

RESUMO

BACKGROUND: ADVANCE compared the efficacy and safety of two antiretroviral first-line combinations (dolutegravir combined with emtricitabine and either tenofovir disoproxil fumarate or tenofovir alafenamide), with a third regimen (efavirenz combined with emtricitabine and tenofovir disoproxil fumarate) previously recommended by WHO. Here, we report the 96-week data for the study. METHODS: This randomised, open-label, non-inferiority phase 3 trial, was done at two research sites in Johannesburg, South Africa, after participant recruitment from 11 public health clinics also in Johannesburg. Eligible participants were aged 12 years or older with HIV-1 infection, who weighed at least 40 kg, had no antiretroviral exposure in the previous 6 months, with a creatinine clearance of more than 60 mL/min (>80 mL per min in individuals aged <19 years), and a plasma HIV-1 RNA concentration of 500 copies per mL or higher. Individuals who were pregnant or had tuberculosis were excluded. Participants were randomly assigned (1:1:1) by study staff using a computerised randomisation system. Randomisation was stratified by age (12 and <19 years and ≥19 years). Participants were randomly assigned to once-daily oral fixed-dose combination tenofovir alafenamide 25 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; once-daily oral fixed-dose combination tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg, and once-daily oral dolutegravir 50 mg; or once-daily oral fixed-dose combination of tenofovir disoproxil fumarate 300 mg, emtricitabine 200 mg, and efavirenz 600 mg. The primary efficacy endpoint was the proportion of participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at week 48, which has been reported previously. Here, we report the key secondary efficacy endpoint of the proportion of participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at the week 96 visit, assessed in all participants who received at least one dose of any study drug, with a prespecified non-inferiority margin of -10%. Safety data, including clinical, dual-energy X-ray absorptiometry and laboratory data, are also reported. This study was registered with ClinicalTrials.gov, NCT03122262. FINDINGS: Between Jan 17, 2017, and May 14, 2018, we screened 1453 individuals, of whom 1053 were enrolled: 351 participants were randomly assigned to the tenofovir alafenamide, emtricitabine, and dolutegravir group, 351 to the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 351 to the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group. All participants received at least one dose of study medication and were included in the primary analysis. At week 96, 276 (79%) of 351 participants in the tenofovir alafenamide, emtricitabine, and dolutegravir group, 275 (78%) of 351 participants in the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 258 (74%) of 351 participants in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group had achieved a plasma HIV-1 RNA concentration of less than 50 copies per mL. Non-inferiority was established in all three comparisons. The proportion of patients with protocol-defined virological failure at week 96 was low in all treatment groups. Participants in the tenofovir alafenamide, emtricitabine, and dolutegravir group had fewer changes in bone density than the two other treatment groups. Mean weight gain was substantial (7·1 kg [SD 7·4] in the tenofovir alafenamide, emtricitabine, and dolutegravir group; 4·3 kg [6·7] in the tenofovir disoproxil fumarate, emtricitabine, and dolutegravir group, and 2·3 kg [7·0] in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group), and was greater among women than men. Ten (3%) of 351 participants in the tenofovir disoproxil fumarate, emtricitabine, and efavirenz group discontinued due to treatment-related adverse events, of which liver dysfunction (n=4) and rash (n=4) were most common. INTERPRETATION: Medium-term and long-term metabolic and clinical consequences of the considerable increase in bodyweight observed in participants given these antiretroviral regimens and the trajectory of this weight gain over time, especially among women, require further study. FUNDING: USAID, Unitaid, South African Medical Research Council, ViiV Healthcare.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , HIV-1/efeitos dos fármacos , Adenina/administração & dosagem , Adenina/análogos & derivados , Adolescente , Adulto , Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/efeitos adversos , Benzoxazinas/administração & dosagem , Composição Corporal , Peso Corporal , Duração da Terapia , Emtricitabina/administração & dosagem , Feminino , Compostos Heterocíclicos com 3 Anéis/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Tenofovir/administração & dosagem , Resultado do Tratamento , Carga Viral , Adulto Jovem
3.
Lancet HIV ; 7(10): e677-e687, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33010241

RESUMO

BACKGROUND: Updated WHO guidelines recommend a dolutegravir-based regimen as the preferred first-line treatment for HIV infection and low-dose efavirenz (400 mg) as an alternative. We aimed to report the non-inferior efficacy of dolutegravir compared with efavirenz 400 mg at week 96. METHODS: We did a multicentre, randomised, open label, phase 3 trial in in three hospitals in Yaoundé, Cameroon, in HIV-1 infected antiretroviral-naive adults with an HIV RNA viral load of greater than 1000 copies per mL to compare dolutegravir 50 mg with efavirenz 400 mg (reference treatment), both combined with lamivudine and tenofovir disoproxil fumarate. The primary endpoint was the proportion with a viral load of less than 50 copies per mL at week 48 (10% non-inferiority margin). The study is registered with ClinicalTrials.gov, NCT02777229 and is ongoing. FINDINGS: Between July, 2016, and August, 2019, of 820 patients assessed, 613 were randomly assigned to receive at least one dose of study medication, with 310 in the dolutegravir group and 303 in the efavirenz 400 mg group. At week 96 in the intention-to-treat analysis, 229 (74%) of 310 patients receiving dolutegravir and 219 (72%) of 303 patients receiving efavirenz, achieved plasma HIV-1 RNA less than 50 copies per mL (difference 1·6%, 95% CI -5·4 to 8·6; p=0.66). Viral load suppression was reached significantly more rapidly in the dolutegravir group (p<0·001). Virological failure (>1000 copies per mL) was observed in 27 patients (eight in the dolutegravir group, among which, three women switched to efavirenz 600 mg because of the dolutegravir teratogeneicity signal, and 19 in the efavirenz 400 mg group). No acquired resistance mutations to dolutegravir were observed against 17 mutations to efavirenz with or without mutations to lamivudine and tenofovir disoproxil fumarate among the 19 efavirenz 400 mg participants with virological failure. Weight gain was greater in the dolutegravir group (median weight gain, 5·0 kg in the dolutegravir group and 3·0 kg in the efavirenz 400 mg group, p<0·001, and incidence of obesity, 22% in the dolutegravir group and 16% in the efavirenz 400 mg group, p=0·043). The incidence of new WHO HIV-related stage 3 and 4 events was similar in each group (12 [4%] in each group). The two groups had similar rates of serious adverse events (28 [9%] of 310 in the dolutegravir group and 21 [7%] of 303 in the efavirenz 400 mg group). 18 deaths were observed during the 96-week follow-up (eight in the dolutegravir group and ten in the efavirenz 400 mg group). INTERPRETATION: The non-inferior efficacy of the dolutegravir-based regimen and non-emergence of dolutegravir resistance at 96 weeks supports its use as a first-line regimen for antiretroviral-naive adults with HIV-1 infection. Viral load suppression was reached more quickly in the dolutegravir group and weight gain was significantly higher. FUNDING: UNITAID and the French National Agency for AIDS Research.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , HIV-1/efeitos dos fármacos , Adulto , Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/efeitos adversos , Terapia Antirretroviral de Alta Atividade/efeitos adversos , Terapia Antirretroviral de Alta Atividade/métodos , Benzoxazinas/administração & dosagem , Contagem de Linfócito CD4 , Duração da Terapia , Feminino , Compostos Heterocíclicos com 3 Anéis/administração & dosagem , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento , Carga Viral , Adulto Jovem
4.
MMWR Morb Mortal Wkly Rep ; 69(42): 1549-1551, 2020 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-33090979

RESUMO

Namibia is an upper-middle income country in southern Africa, with a population of approximately 2.5 million (1). On March 13, 2020, the first two cases of coronavirus disease 2019 (COVID-19) in Namibia were identified among recently arrived international travelers. On March 17, Namibia's president declared a state of emergency, which introduced measures such as closing of all international borders, enactment of regional travel restrictions, closing of schools, suspension of gatherings, and implementation of physical distancing measures across the country. As of October 19, 2020, Namibia had reported 12,326 laboratory-confirmed COVID-19 cases and 131 COVID-19-associated deaths. CDC, through its Namibia country office, as part of ongoing assistance from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) provided technical assistance to the Ministry of Health and Social Services (MoHSS) for rapid coordination of the national human immunodeficiency virus (HIV) treatment program with the national COVID-19 response.


Assuntos
Infecções por Coronavirus/prevenção & controle , Infecções por HIV/tratamento farmacológico , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Desenvolvimento de Programas , Fármacos Anti-HIV/uso terapêutico , Serviços de Saúde Comunitária/organização & administração , Infecções por Coronavirus/epidemiologia , Humanos , Namíbia/epidemiologia , Pneumonia Viral/epidemiologia
5.
PLoS Med ; 17(9): e1003325, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32936795

RESUMO

BACKGROUND: Current World Health Organization (WHO) antiretroviral therapy (ART) guidelines define virologic failure as two consecutive viral load (VL) measurements ≥1,000 copies/mL, triggering empiric switch to next-line ART. This trial assessed if patients with sustained low-level HIV-1 viremia on first-line ART benefit from a switch to second-line treatment. METHODS AND FINDINGS: This multicenter, parallel-group, open-label, superiority, randomized controlled trial enrolled patients on first-line ART containing non-nucleoside reverse transcriptase inhibitors (NNRTI) with two consecutive VLs ≥100 copies/mL, with the second VL between 100-999 copies/mL, from eight clinics in Lesotho. Consenting participants were randomly assigned (1:1), stratified by facility, demographic group, and baseline VL, to either switch to second-line ART (switch group) or continued first-line ART (control group; WHO guidelines). The primary endpoint was viral suppression (<50 copies/mL) at 36 weeks. Analyses were by intention to treat, using logistic regression models, adjusted for demographic group and baseline VL. Between August 1, 2017, and August 7, 2019, 137 individuals were screened, of whom 80 were eligible and randomly assigned to switch (n = 40) or control group (n = 40). The majority of participants were female (54 [68%]) with a median age of 42 y (interquartile range [IQR] 35-51), taking tenofovir disoproxil fumarate/lamivudine/efavirenz (49 [61%]) and on ART for a median of 5.9 y (IQR 3.3-8.6). At 36 weeks, 22/40 (55%) participants in the switch versus 10/40 (25%) in the control group achieved viral suppression (adjusted difference 29%, 95% CI 8%-50%, p = 0.009). The switch group had significantly higher probability of viral suppression across different VL thresholds (<20, <100, <200, <400, and <600 copies/mL) but not for <1,000 copies/mL. Thirty-four (85%) participants in switch group and 21 (53%) in control group experienced at least one adverse event (AE) (p = 0.002). No hospitalization or death or other serious adverse events were observed. Study limitations include a follow-up period too short to observe differences in clinical outcomes, missing values in CD4 cell counts due to national stockout of reagents during the study, and limited generalizability of findings to other than NNRTI-based first-line ART regimens. CONCLUSIONS: In this study, switching to second-line ART among patients with sustained low-level HIV-1 viremia resulted in a higher proportion of participants with viral suppression. These results endorse lowering the threshold for virologic failure in future WHO guidelines. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov, NCT03088241.


Assuntos
Infecções por HIV/tratamento farmacológico , Viremia/tratamento farmacológico , Adulto , Fármacos Anti-HIV/uso terapêutico , Antirretrovirais/uso terapêutico , Terapia Antirretroviral de Alta Atividade/métodos , Quimioterapia Combinada , Feminino , Soropositividade para HIV/tratamento farmacológico , HIV-1/efeitos dos fármacos , HIV-1/metabolismo , Humanos , Lesoto/epidemiologia , Masculino , Pessoa de Meia-Idade , Carga Viral
6.
Medicine (Baltimore) ; 99(39): e22352, 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32991450

RESUMO

BACKGROUND: Antiretroviral therapy for HIV in sub-Saharan Africa has transformed the highly infectious virus to a stable chronic condition, with the advent of Highly active antiretroviral therapy (HAART). The longterm effects of HAART on the oral health of children are understudied. OBJECTIVE: To compare the effect of lopinavir-ritonavir and lamivudine on oral health indicators (dental caries, gingivitis, tooth eruption, and oral health related quality of life) in 5 to 7 year old HIV-1 exposed uninfected children from the ANRS 12174 trial. METHODS: This study used data collected in 2017 among children aged 5 to 7 years from the Ugandan site of the ANRS 12174 randomized trial (ClinicalTrials.gov no: NCT00640263) implemented between 2009 and 2012 in Mbale district, Eastern Uganda. The intervention was lopinavir-ritonavir or lamuvudine treatment to prevent vertical HIV-1 transmission. One hundred thirty-seven and 139 children were randomized to receive lopinavir-ritonavir or lamivudine treatment at day 7 postpartum to compare efficacy of prevention of vertical HIV-1 transmission. At follow up, the children underwent oral examination using the World Health Organization methods for field conditions. The oral health related quality of life was assessed using the early childhood oral health impact scale. Negative binomial and logistic regression were used for the analysis of data. MAIN OUTCOME MEASURES: Dental caries, gingivitis, tooth eruption, and oral health related quality of life) in 5 to 7 year old HIV-1 exposed uninfected children. RESULTS: The prevalence of dental caries was 48% in the study sample: 49% in the lopinavir-ritonavir arm and 48% in the lamivudine treatment group. The corresponding mean decayed missing filled teeth and standard deviation was 1.7 (2.4) and 2.3 (3.7) The mean number (standard deviation) of erupted permanent teeth was 3.8 (3.7) and 4.6 (3.9) teeth in the lopinavir- and lamivudine group, respectively. The prevalence of reported impacts on oral health was 7% in the lopinavir-ritonavir and 18% in the lamivudine group. Gingivitis had a prevalence of 7% in the lopinavir-ritonavir and 14% lamivudine treatment group. The regression analysis revealed 70% less reported impacts on oral health in lopinavir-ritonavir group than the lamivudine treatment group with an incidence rate ratio of 0.3 (95% confidence interval: 0.1-0.9). CONCLUSIONS: HIV exposed uninfected infants in the lopinavir-ritonavir group reported less impacts on oral health than the lamivudine treatment group. Dental caries, gingivitis, and tooth eruption were not significantly affected by the treatment lopinavir-ritonavir or lamivudine. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER: NCT00640263.


Assuntos
Antirretrovirais/uso terapêutico , Terapia Antirretroviral de Alta Atividade/métodos , Infecções por HIV/tratamento farmacológico , Saúde Bucal/estatística & dados numéricos , Fármacos Anti-HIV/farmacologia , Fármacos Anti-HIV/uso terapêutico , Estudos de Casos e Controles , Criança , Pré-Escolar , Cárie Dentária/tratamento farmacológico , Cárie Dentária/epidemiologia , Quimioterapia Combinada , Feminino , Gengivite/tratamento farmacológico , Infecções por HIV/prevenção & controle , Infecções por HIV/transmissão , HIV-1/efeitos dos fármacos , Humanos , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Lamivudina/farmacologia , Lamivudina/uso terapêutico , Lopinavir/farmacologia , Lopinavir/uso terapêutico , Masculino , Avaliação de Resultados em Cuidados de Saúde , Prevalência , Qualidade de Vida , Ritonavir/farmacologia , Ritonavir/uso terapêutico , Erupção Dentária/efeitos dos fármacos , Uganda/epidemiologia
7.
PLoS One ; 15(8): e0238052, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32866163

RESUMO

The integrase inhibitor dolutegravir was included in initial antiretroviral therapy in Brazil in January 2017. Studies have demonstrated that the efficacy and safety of antiretrovirals have improved with the introduction of new classes of antiretrovirals, such as integrase inhibitors. This study aimed to estimate the frequency of individuals with a virologic response by week 24 of antiretroviral treatment and to describe the adverse events of the regimen containing dolutegravir. This was a cohort of people living with HIV followed up at a referral hospital. Patients were included who had initiated their first treatment between January and August 2017. Data were obtained from medical records, the Drug Logistics Management System and from the Laboratory Tests Control System. Two hundred and twenty-two patients were included for the tolerability analysis and one hundred and thirty-seven for the virologic response analysis. The mean age was 34 years, the median time between diagnosis and initiating treatment was 1.9 months and the median time on antiretroviral therapy was 13.2 months. The frequency of adverse events was 10% (95% CI: 7% to 15.2%), of these, amongst the most frequent events, 91% presented gastrointestinal effects, and 47.8% neuropsychiatric. By week 24 the estimated incidence of virologic response was 89.1% (95% CI: 83% to 93.5%), with an increase during the first 6 months in the number of T-CD4 lymphocytes of 50.7 cells/mm 3 (95% CI: 42 to 59.3). Initial antiretroviral regimens containing dolutegravir were well tolerated and effective in viral suppression during the first 24 weeks after initiating treatment. The occurrence of adverse events was low, either mild or moderate.


Assuntos
Fármacos Anti-HIV/efeitos adversos , Fármacos Anti-HIV/farmacologia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , Compostos Heterocíclicos com 3 Anéis/efeitos adversos , Compostos Heterocíclicos com 3 Anéis/farmacologia , Segurança , Adolescente , Adulto , Idoso , Fármacos Anti-HIV/uso terapêutico , Feminino , Compostos Heterocíclicos com 3 Anéis/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Virologia
8.
Yonsei Med J ; 61(9): 826-830, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32882767

RESUMO

We retrospectively reviewed patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections who were admitted to an intensive care unit in Daegu, South Korea. The outcomes of patients who did (cases) or did not (controls) receive darunavir-cobicistat (800-150 mg) therapy were compared. Fourteen patients received darunavir-cobicistat treatment, and 96 received other antiviral therapy (controls). Overall, the darunavir-cobicistat group comprised patients with milder illness, and the crude mortality rate of all patients in the darunavir-cobicistat group was lower than that in the controls [odds ratio (OR) 0.20, 95% confidence interval (CI) 0.04-0.89, p=0.035]. After 1:2 propensity-score matching, there were 14 patients in the darunavir-cobicistat group, and 28 patients in the controls. In propensity score-matched analysis, the darunavir-cobicistat group had lower mortality than the controls (OR 0.07, 95% CI 0.01-0.52, p=0.009). In conclusion, darunavir-cobicistat therapy was found to be associated with a significant survival benefit in critically ill patients with SARS-CoV-2 infection.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Cobicistat/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Darunavir/uso terapêutico , Inibidores da Protease de HIV/uso terapêutico , Pneumonia Viral/tratamento farmacológico , Adulto , Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/efeitos adversos , Betacoronavirus , Estudos de Casos e Controles , Cobicistat/administração & dosagem , Cobicistat/efeitos adversos , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/mortalidade , Estado Terminal , Darunavir/administração & dosagem , Darunavir/efeitos adversos , Feminino , Inibidores da Protease de HIV/administração & dosagem , Inibidores da Protease de HIV/efeitos adversos , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/mortalidade , República da Coreia/epidemiologia , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
9.
Eur J Cancer ; 138: 109-112, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32871524
10.
PLoS One ; 15(9): e0237770, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32966293

RESUMO

OBJECTIVES: The aim of this proof-of-concept study is to test feasibility and efficacy of NVP plus Lamivudine (3TC) as novel simplified HIV maintenance dual therapy (DT) strategy. METHODS: Patients under combined antiretroviral treatment (cART) with fully suppressed HIV plasma viral load (pVL) >24 months-whereof >6 months on an NVP- containing regimen-were switched to oral NVP plus 3TC for 24 weeks. Patients could then decide whether to continue DT or return to the previous cART. HIV pVL was monitored monthly until week 144. The primary outcome was confirmed viral failure (RNA >100 copies/ml). Low-level detection of HIV-RNA in plasma was compared in each patient with pre-study viral load measurements. RESULTS: Twenty patients were included, switched to DT and all completed week 24. One patient decided thereafter to discontinue study participation for personal reasons. After a total of 144 observation weeks, none of the patients failed. The frequency of low- level HIV-RNA detection was not different from the period before randomization. CONCLUSIONS: Our findings are surprising but given the nature of a proof-of-concept study, the results do not support the use of this dual regimen. However, as this dual HIV maintenance strategy was feasible and effective, over a period of 144 weeks, we suggest NVP plus 3TC warrants further evaluation as potential maintenance option in patients tolerating nevirapine. A properly sized multicentre non-inferiority trial is ongoing to further evaluate the value of this DT maintenance strategy.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , HIV-1/fisiologia , Lamivudina/uso terapêutico , Estudo de Prova de Conceito , Fármacos Anti-HIV/farmacologia , Feminino , Infecções por HIV/sangue , HIV-1/efeitos dos fármacos , HIV-1/genética , Humanos , Lamivudina/farmacologia , Masculino , Pessoa de Meia-Idade , Nevirapina/uso terapêutico , RNA Viral/sangue
11.
Medicine (Baltimore) ; 99(37): e21661, 2020 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-32925712

RESUMO

To support optimal third-line antiretroviral therapy (ART) selection in Namibia, we investigated the prevalence of HIV drug resistance (HIVDR) at time of failure of second-line ART. A cross-sectional study was conducted between August 2016 and February 2017. HIV-infected people ≥15 years of age with confirmed virological failure while receiving ritonavir-boosted protease inhibitor (PI/r)-based second-line ART were identified at 15 high-volume ART clinics representing over >70% of the total population receiving second-line ART. HIVDR genotyping of dried blood spots obtained from these individuals was performed using standard population sequencing methods. The Stanford HIVDR algorithm was used to identify sequences with predicted resistance; genotypic susceptibility scores for potential third-line regimens were calculated. Two hundred thirty-eight individuals were enrolled; 57.6% were female. The median age and duration on PI/r-based ART at time of enrolment were 37 years and 3.46 years, respectively. 97.5% received lopinavir/ritonavir-based regimens. The prevalence of nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and PI/r resistance was 50.6%, 63.1%, and 13.1%, respectively. No significant association was observed between HIVDR prevalence and age or sex. This study demonstrates high levels of NRTI and NNRTI resistance and moderate levels of PI resistance in people receiving PI/r-based second-line ART in Namibia. Findings underscore the need for objective and inexpensive measures of adherence to identify those in need of intensive adherence counselling, routine viral load monitoring to promptly detect virological failure, and HIVDR genotyping to optimize selection of third-line drugs in Namibia.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Farmacorresistência Viral , Infecções por HIV/tratamento farmacológico , Adolescente , Adulto , Estudos Transversais , Feminino , HIV/efeitos dos fármacos , Humanos , Lopinavir/uso terapêutico , Masculino , Pessoa de Meia-Idade , Namíbia/epidemiologia , Prevalência , Inibidores da Transcriptase Reversa/uso terapêutico , Ritonavir/uso terapêutico , Falha de Tratamento , Adulto Jovem
12.
Mem Inst Oswaldo Cruz ; 115: e200082, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32935750

RESUMO

Respiratory failure (RF) is the main cause of hospital admission in HIV/AIDS patients. This study assessed comorbidities and laboratory parameters in HIV/AIDS inpatients with RF (N = 58) in relation to those without RF (N = 36). Tuberculosis showed a huge relative risk and platelet counts were slightly higher in HIV/AIDS inpatients with RF. A flow cytometry assay for reactive oxygen species (ROS) showed lower levels in platelets of these patients in relation to the healthy subjects. However, when stimulated with adrenaline, ROS levels increased in platelets and platelet-derived microparticles of HIV/AIDS inpatients, which may increase the risk of RF during HIV and tuberculosis (HIV-TB) coinfection.


Assuntos
Micropartículas Derivadas de Células/metabolismo , Infecções por HIV/sangue , HIV/imunologia , Espécies Reativas de Oxigênio/sangue , Insuficiência Respiratória/complicações , Fármacos Anti-HIV/uso terapêutico , Biomarcadores/sangue , Plaquetas , Citometria de Fluxo , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Humanos , Insuficiência Respiratória/sangue
13.
PLoS One ; 15(8): e0236933, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32866154

RESUMO

BACKGROUND: Persons living with human immunodeficiency virus (HIV) are at a greater risk of developing tuberculosis (TB) compared to people without HIV and of developing complications due to the complexity of TB/HIV coinfection management. METHODS: During 2013-2017, the Centers for Disease Control and Prevention (CDC) funded 5 TB Regional Training and Medical Consultation Centers (RTMCCs) (now known as TB Centers of Excellence or COEs) to provide medical consultation to providers for TB disease and latent TB infection (LTBI), with data entered into a Medical Consultation Database (MCD). Descriptive analyses of TB/HIV-related consultations were conducted using SAS® software, version [9.4] to determine the distribution of year of consultation, medical setting and provider type, frequency of consultations regarding a pediatric (<18 years) patient, and to categorize key concepts and themes arising within consultation queries and medical consultant responses. RESULTS: Of 14,586 consultations captured by the MCD in 2013-2017, 544 (4%) were categorized as TB/HIV-related, with 100 (18%) received in 2013, 129 (24%) in 2014, 104 (19%) in 2015, 117 (22%) in 2016, and 94 (17%) in 2017. Most TB/HIV consultations came from nurses (54%) or physicians (43%) and from local (65%) or state health departments (10%). Only 17 (3%) of HIV-related consultations involved pediatric cases. Off the 544 TB/HIV consultations, 347 (64%) concerned the appropriate treatment regimen for TB/HIV or LTBI/HIV for a patient on or not on antiretroviral therapy (ART). CONCLUSIONS: The data support a clear and ongoing gap in areas of specialized HIV knowledge by TB experts that could be supplemented with proactive educational outreach. The specific categories of TB/HIV inquiries captured by this analysis are strategically informing future targeted training and educational activities planned by the CDC TB Centers of Excellence, as well as guiding HIV educational efforts at regional and national TB meetings.


Assuntos
Centers for Disease Control and Prevention, U.S./economia , Infecções por HIV/complicações , Pessoal de Saúde/economia , Pessoal de Saúde/educação , Encaminhamento e Consulta/economia , Tuberculose/complicações , Fármacos Anti-HIV/efeitos adversos , Fármacos Anti-HIV/uso terapêutico , Antituberculosos/efeitos adversos , Antituberculosos/uso terapêutico , Infecções por HIV/tratamento farmacológico , Humanos , Segurança , Tuberculose/tratamento farmacológico , Estados Unidos
14.
Top Antivir Med ; 28(2): 439-454, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32886464

RESUMO

At the 2020 Conference on Retroviruses and Opportunistic Infections, held virtually as a result of the emerging COVID-19 pandemic, trends in the HIV epidemic were highlighted, with decreasing HIV incidence reported across several countries, although key regions remain heavily impacted, including the US South. Adolescent girls and young women, men who have sex with men (MSM), transgender persons, and people who inject drugs continue to experience a high burden of new infections. Sexually transmitted infections during pregnancy can lead to a number of adverse outcomes in infants; novel strategies to detect and treat these infections are needed. Innovative HIV testing strategies, including self-testing and assisted partner services, are expanding the reach of testing; however, linkage to care can be improved. Novel preexposure prophylaxis (PrEP) delivery strategies are increasing uptake of PrEP in different groups, although adherence and persistence remain a challenge. Use of on-demand PrEP is increasing among MSM in the US. Strategies are needed to address barriers to PrEP uptake and persistence among cis- and transgender women. Several novel regimens for postexposure prophylaxis show promise.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por Coronavirus/epidemiologia , Infecções por HIV/epidemiologia , Pneumonia Viral/epidemiologia , Profilaxia Pré-Exposição/organização & administração , Saúde Pública , Doenças Sexualmente Transmissíveis/epidemiologia , Congressos como Assunto , Infecções por Coronavirus/diagnóstico , Feminino , Saúde Global , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Humanos , Masculino , Infecções Oportunistas/diagnóstico , Infecções Oportunistas/epidemiologia , Pandemias/prevenção & controle , Pneumonia Viral/diagnóstico , Prevenção Primária/organização & administração , Projetos de Pesquisa , Infecções por Retroviridae/diagnóstico , Infecções por Retroviridae/epidemiologia , Fatores de Risco , Minorias Sexuais e de Gênero/estatística & dados numéricos , Doenças Sexualmente Transmissíveis/prevenção & controle , Estados Unidos , Interface Usuário-Computador
15.
Top Antivir Med ; 28(2): 455-458, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32886465

RESUMO

Due to COVID-19, this year marked the first virtual Conference on Retroviruses and Opportunistic Infections (CROI) in the conference's 27-year history. There were important studies presented that provided new insights into the prevention, diagnosis, and treatment of tuberculosis (TB) and other HIV coinfections. Highlights related to TB and HIV coinfections from this year's meeting are reviewed below.


Assuntos
Coinfecção/epidemiologia , Infecções por HIV/epidemiologia , Infecções Oportunistas/epidemiologia , Saúde Pública , Tuberculose/epidemiologia , Adulto , Fármacos Anti-HIV/uso terapêutico , Antituberculosos/uso terapêutico , Coinfecção/diagnóstico , Coinfecção/tratamento farmacológico , Controle de Doenças Transmissíveis/organização & administração , Congressos como Assunto , Criptococose/diagnóstico , Criptococose/tratamento farmacológico , Criptococose/epidemiologia , Feminino , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Humanos , Lactente , Masculino , Micoses/diagnóstico , Micoses/tratamento farmacológico , Micoses/epidemiologia , Infecções Oportunistas/diagnóstico , Infecções Oportunistas/tratamento farmacológico , Gravidez , Prevalência , Prevenção Primária/métodos , Medição de Risco , Análise de Sobrevida , Tuberculose/diagnóstico , Tuberculose/tratamento farmacológico , Tuberculose Resistente a Múltiplos Medicamentos/diagnóstico , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Tuberculose Resistente a Múltiplos Medicamentos/epidemiologia , Interface Usuário-Computador , Adulto Jovem
17.
Lancet Glob Health ; 8(10): e1305-e1315, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32971053

RESUMO

BACKGROUND: Community-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART. METHODS: We did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0·95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992. FINDINGS: Between May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men. Retention at the month 12 visit was 95% (n=1253). At 12 months, community-based ART increased viral suppression compared with the clinic group (306 [74%] vs 269 [63%], RR 1·18, 95% CI 1·07-1·29; psuperiority=0·0005) and the hybrid approach was non-inferior (282 [68%] vs 269 [63%], RR 1·08, 0·98-1·19; pnon-inferiority=0·0049). Community-based ART increased viral suppression among men (73%, RR 1·34, 95% CI 1·16-1·55; psuperiority<0·0001) as did the hybrid approach (66%, RR 1·19, 1·02-1·40; psuperiority=0·026), compared with clinic-based ART (54%). Viral suppression was similar for men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group. With efficient scale-up, community-based ART could cost US$275-452 per person reaching viral suppression. Community-based ART was considered safe, with few adverse events. INTERPRETATION: In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender. Community-based ART should be implemented and evaluated in different contexts for people with detectable viral load. FUNDING: The Bill & Melinda Gates Foundation; the University of Washington and Fred Hutch Center for AIDS Research; the Wellcome Trust; the University of Washington Royalty Research Fund; and the University of Washington King K Holmes Endowed Professorship in STDs and AIDS.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Serviços de Saúde Comunitária/métodos , Assistência à Saúde/métodos , Infecções por HIV/tratamento farmacológico , Adolescente , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , África do Sul , Resultado do Tratamento , Uganda , Adulto Jovem
18.
BMC Infect Dis ; 20(1): 704, 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32977745

RESUMO

INTRODUCTION: In sub-Saharan Africa, considerable HIV-burden exists among women. Anti-retroviral (ARV) based prevention products could decrease this burden, and their uptake could be increased if they also protect against pregnancy and sexually transmitted infections (STI). METHODS: A discrete choice experiment (DCE) was undertaken in South Africa (2015) through a household survey of adult females (n = 158) and adolescent girls (n = 204) who self-reported HIV-negative status. The DCE was used to project the uptake (percentage using product) of oral pre-exposure prophylaxis (PrEP), vaginal rings, and injectable long-lasting ARV agents among these women, and how uptake could depend on whether these products protect against pregnancy or STI acquisition. Uptake estimates were used to model how each product could decrease a women's HIV acquisition risk. RESULTS: In adolescent women, there will be limited uptake (< 6% for any product) and impact (< 4% decrease in HIV acquisition risk) of new products unless they provide pregnancy protection, which could quadruple use and impact. Adult women have weaker preference for pregnancy protection, with moderate use (< 17% for each) and impact (< 14 percentage point decrease) if they only provide HIV protection. All women had highest preference for injectable ARVs, with oral PrEP having high preference if injectable ARVs are not available. Adult women will use the ring, but adolescent women will not. Importantly, even with three additional prevention products, all providing pregnancy and STI protection, > 14% of women will remain unprotected and > 31% of the baseline acquisition risk will remain. CONCLUSIONS: Incorporating multiple prevention components into new ARV-based prevention products may increase their uptake and impact among women.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Dispositivos Anticoncepcionais Femininos , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , HIV , Profilaxia Pré-Exposição/métodos , Adolescente , Adulto , Feminino , Infecções por HIV/virologia , Humanos , Gravidez , Autorrelato , África do Sul/epidemiologia , Adulto Jovem
19.
Medicine (Baltimore) ; 99(32): e21410, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769871

RESUMO

It is often assumed that children and their caregivers either stay in care together or discontinue together, but data is lacking on caregiver-child retention concordance. We sought to describe the pattern of care among a cohort of human immunodeficiency virus (HIV) infected children and mothers enrolled in care at the Manhiça District Hospital (MDH).This was a retrospective review of routine HIV clinical data collected under a larger prospective HIV cohort study at MDH. Children enrolling HIV care from January 2013 to November 2016 were identified and matched to their mother's HIV clinical data. Retention in care for mothers and children was assessed at 24 months after the child's enrolment. Multinomial logistic regression was performed to evaluate variables associated with retention discordance.For the 351 mother-child pairs included in the study, only 39% of mothers had concordant care status at baseline (23% already active in care, 16% initiated care concurrently with their children). At 24-months follow up, a total of 108 (31%) mother-child pairs were concordantly retained in care, 88 (26%) pairs were concordantly lost to follow up (LTFU), and 149 (43%) had discordant retention. Pairs with concurrent registration had a higher probability of being concordantly retained in care. Children who presented with advanced clinical or immunological stage had increased probability of being concordantly LTFU.High rates of LTFU as well as high proportions of discordant retention among mother-child pairs were found. Prioritization of a family-based care model that has the potential to improve retention for children and caregivers is recommended.


Assuntos
Medicina de Família e Comunidade , Infecções por HIV/psicologia , Infecções por HIV/terapia , Perda de Seguimento , Mães/psicologia , Cooperação do Paciente/psicologia , Adulto , Fármacos Anti-HIV/uso terapêutico , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Moçambique
20.
Malawi Med J ; 32(1): 3-7, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32733652

RESUMO

Introduction: Cryptococcal meningitis (CM) is the most common systemic fungal infection in patients with HIV infection. Rapid diagnosis and timely initiation of antifungal therapy are key to reducing mortality rate associated with CM. This study aims to evaluate the ability of four different diagnostic tests (Gram stain, India ink, and two types of commercial lateral flow assay [LFA]) to identify CM-positive patients and to compare the sensitivity and specificity of these tests. Methods: This was a prospective cross-sectional study on diagnostic tests accuracy conducted in Northern Malawi. The target population was HIV-infected adult patients presenting with features of meningitis. Four types of diagnostic tests were conducted: India ink, Gram stain, and two types of commercial lateral flow assay (LFA) (Immy, Inc., OK, USA and Dynamiker Biotechnology (Tianjin) Co., Ltd), Singapore). Culture was conducted as the reference standard. Results: A total of 265 samples were collected. The rate of positive CM detection ranged from 6.4% (using India ink) to 14.3% (using LFA). India ink exhibited the lowest sensitivity of 54.8% (95% confidence interval [CI]: 36.0%-72.7%), followed by Gram stain (61.3%; 95% CI: 42.2%-78.2%). The Dynamiker LFA exhibited the highest sensitivity of 100.0% (95% CI: 90.0%-100.0%) but a lower specificity (97.0%; 93.9%-98.8%) compared to the Immy LFA (98.3%; 95% CI: 95.7%-99.5%). Conclusion: LFA diagnostic methods have the potential to double the detection rate of CM-positive patients in resource-limited countries such as Malawi. As such, LFAs should be considered to become the main diagnostic tests used for CM diagnostics in these countries. Our data indicate that LFAs may be the best method for diagnosing CM and exhibits the highest diagnostic accuracy as it has shown that it outperforms cell culture, the current gold standard.


Assuntos
Infecções Oportunistas Relacionadas com a AIDS/epidemiologia , Antifúngicos/uso terapêutico , Antígenos de Fungos/sangue , Cryptococcus/isolamento & purificação , Infecções por HIV/complicações , Meningite Criptocócica/diagnóstico , Infecções Oportunistas Relacionadas com a AIDS/sangue , Infecções Oportunistas Relacionadas com a AIDS/diagnóstico , Adulto , Fármacos Anti-HIV/uso terapêutico , Contagem de Linfócito CD4 , Estudos Transversais , Cryptococcus/imunologia , Feminino , Infecções por HIV/tratamento farmacológico , Humanos , Malaui/epidemiologia , Masculino , Meningite Criptocócica/sangue , Meningite Criptocócica/tratamento farmacológico , Sistemas Automatizados de Assistência Junto ao Leito , Estudos Prospectivos , Sensibilidade e Especificidade
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